Ensayos clínicos

Inclusion Criteria:

• Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of COVID-19.
• Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures.
• Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
• Male or non-pregnant female adults ≥ 18 years of age at time of enrollment.
• Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as determined by PCR or other commercial or public health assay in any specimen.
• Ongoing illness of any duration, and at least one of the following:
  • Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.).
  • Blood oxygen saturation (SpO2) ≤ 94% on room air.
  • Requiring supplemental oxygen.
  • Requiring mechanical ventilation or ECMO.
• Women of childbearing potential must agree to either abstinence or use at least one primary form of contraception not including hormonal contraception from the time of screening through Day 60.
• Agrees to not participate in another intervention trial for the treatment of COVID-19 through Day 60.

Exclusion Criteria:

• ALT or AST > 5 times the upper limit of normal.
• Estimated glomerular filtration rate (eGFR) < 30 mL/min (including patients receiving hemodialysis or hemofiltration).
• Neutropenia (absolute neutrophil count < 1000 cells/μL) (<1.0 x 10^3/μL or < 1.0 GI/L).
• Lymphopenia (absolute lymphocyte count < 200 cells/μL) (< 0.20 x 10^3/μL or < 0.20 GI/L).
• Pregnancy or breast feeding.
• Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours.
• Known Allergy to any study medication.
• Received cytotoxic or biologic treatments (such as anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], IL-17, or T-cell or B-cell targeted therapies (e.g., rituximab), tyrosine kinase inhibitors including baricitinib, TNF inhibitors, or interferon within 4 weeks or 5 half-lives prior to screening. Steroid dependency defined as need for prednisone at a dose > 10 mg (or equivalent) for > 1 month within 2 weeks of screening is exclusionary.
  • Note 1: Dexamethasone (at a dose of 6 mg per day for up to 10 days) is permitted for the treatment of COVID-19 in patients who are already mechanically ventilated and in patients who require supplemental oxygen at screening, but who are not mechanically ventilated in accordance with national guidelines.
  • Note 2: Infusion of convalescent plasma is also allowed.
• Based on medical history and concomitant therapies that would suggest infection, have suspected clinical diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening required).
• Based on medical history and concomitant therapies that would suggest infection, suspected serious, active bacterial, fungal, viral (including, but not limited to, active HBV, HCV, or HIV/AIDS).
• Have received any live vaccine (that is, live attenuated) within 3 months before screening, or intend to receive a live vaccine (or live attenuated) during the study.
  • Note: Use of non-live (inactivated) vaccinations is allowed for all participants.
• Severe hepatic impairment (defined as liver cirrhosis Child stage C).
• Current severe heart failure (New York Heart Association [NYHA] III-IV).
• In the Investigator's judgment, the patient has any advanced organ dysfunction that would not make participation appropriate.